Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma

This work aims to study the peripapillary and macular microvascular changes in primary open angle and primary angle closure glaucoma using Optical Coherence Tomography Angiography (OCTA).

Study Overview

• Status: Completed
• Conditions: Glaucoma,Primary Open-Angle ,Primary Angle Closure
• Intervention / Treatment: Device: Optical coherence tomography angiography

Detailed Description

After approval of the local institutional ethics committee and local institutional review board, all patients presenting to the outpatient clinic of the department of Ophthalmology in the universities has been subjected to routine ophthalmological examination including: best corrected visual acuity (BCVA), Slit-lamp evaluation of anterior segment, IOP by Goldmann applanation tonometer, Gonioscopy using gonio contact lens, Fundus examination by indirect opthalmoscope with history taking focusing on positive family history of glaucoma after a detailed informed consent was signed by eligible patients and investigated by OCTA of the Peripapillary and Macular vascular density on presentation using AngiVue (Optovue, Inc., Fremont, CA, USA).

Data analysis performed using the Statistical Package of Social Science (SPSS) software version 22 in windows 7 (SPSS Inc., Chicago, IL, USA) Simple descriptive statistical analysis in the form of numbers and percentages of qualitative data, and arithmetic means as central tendency measurement, standard deviations as a measure of dispersion of quantitative parametric data.

For quantitative parametric data: Independent samples test was used to compare quantitative measures between two independent groups, One-way analysis of variance ANOVA test used to compare quantitative measures between more than two independent groups of quantitative data with the benferroni Post-HOC to test the significance between each two groups, Paired t-test used to compare two dependent quantitative data.

For qualitative data Chi square test used to compare between two or more than two qualitative groups.

Bivariate Pearson correlation test to test the association between variables The probability value (P-value) < 0.05 was considered as statistical significant

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • Athar Mohamed Mohamed Makhlouf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with primary open angle ,primary angle closure glaucoma and control patients

Description

Inclusion Criteria:

• Age ≥ 18 years old.
• Fulfilling Diagnostic criteria of PACG patients :occluded angle by gonioscopy in which > 180˚ of trabecular meshwork cannot be seen , IOP>21, Optic disc and RNFL damage due to glaucoma
• Diagnosed POAG patient: open anterior chamber angle ,IOP>21 ,Optic disc and RNFL damage due to glaucoma
• Healthy patient: normal anterior chamber, open angle and normal fundus.

Exclusion Criteria:

• History of other causes of optic neuropathy.
• History of systemic diseases. (HTN, DM, Cardiac).
• Previous ocular surgeries or Laser iridotomy.
• Poor quality of OCTA image less than 4/10.
• Refractive errors > 6 diopters sphere, >3 diopter cylinder
• Poor cooperation or fixation with the OCTA examination.
• Secondary causes of glaucoma
• Media opacity that interfere with quality of image (dense cataract,corneal opacity,…)
• Previous acute attack of ACG

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
interventional details : diagnostic test OCTA macula and ONH; interventional details : diagnostic test OCTA macula and ONH in the 3 groups	Device: Optical coherence tomography angiography; diagnostic test OCTA macula and ONH

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OCTA macula and ONH	macular 6*6,3*3 and peripapillary vessel density	We will recruit patient that include the inclusion criteria from april2022 to july 2023

Collaborators and Investigators

• Sponsor: Omar Said

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): July 20, 2023
• Study Completion (Actual): July 20, 2023

Study Registration Dates

• First Submitted: August 12, 2023
• First Submitted That Met QC Criteria: August 12, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 12, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure
• Other Study ID Numbers: M557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No